HUMAN TEMPORAL BONE RESEARCH RESOURCE ENHANCEMENT CONSORTIUM
RELEASE DATE: July 7, 2004
RFA Number: RFA-DC-04-002 (This RFA has been modified, see RFA-DC-06-001)
EXPIRATION DATE: November 16, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.173
LETTER OF INTENT RECEIPT DATES: October 15, 2004
APPLICATION RECEIPT DATES: November 15, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this initiative is to solicit applications that will
enhance the utility of human temporal bones (HTBs) for auditory and
vestibular research. The research projects proposed in response to this
RFA must address the collaborative development of a uniform protocol
for HTB (and related brain tissue) acquisition and processing, and for
the application of modern molecular-biologic assays to HTB research.
RESEARCH OBJECTIVES
A. Background
Clinicopathologic correlation informs our understanding of normal and
disordered human processes, including those underlying hearing, balance
and facial nerve function. Housed in the temporal bone, the inner ear
structures subserving hearing and balance are inaccessible during life,
rendering infeasible the conventional techniques of pathologic
examination, such as biopsy/surgical excision. Consequently, the
assessment of auditory and vestibular structures necessitates the post
mortem study of temporal bones.
The acquisition, processing, and evaluation of HTBs are expensive and
time-consuming endeavors that require specialized equipment and
personnel, which lie outside the expertise of conventional human
pathology laboratories. Accordingly, these research endeavors have been
relegated to specialized HTB laboratories.
In 1992 NIDCD established the NIDCD National Temporal Bone, Hearing and
Balance Pathology Resource Registry (“the Registry”) to promote HTB
research by serving as a national resource for researchers and the
public. Despite the success of the Registry in accomplishing its tasks,
the number of active HTB laboratories and the population of researchers
engaged in HTB research have dwindled to near extinction.
In order to assess the needs of HTB research, both in terms of
maintaining active laboratories and encouraging new researchers into
the field, the NIDCD sponsored a September 2003 workshop entitled
“Temporal Bone Histopathologic Research: Laboratories and Research
Training”. The Workshop participants concluded that: there is a need
for funds to support the basic acquisition and processing of HTBs;
there is a need for a unified protocol for processing HTBs; and, there
is a need for a concerted effort to “modernize” HTB research.
This Human Temporal Bone Research Resource Enhancement Consortium
(“Consortium”) RFA aims to encourage, through a multidisciplinary,
collaborative effort, the development of a unified protocol (or
protocols) for HTB acquisition (and related brain tissue) and
processing that facilitates modern molecular biologic assessment.
B. Objective
The objective of this RFA is to solicit applications that will enhance
the utility of HTBs to modern auditory/vestibular research. Funding
through this RFA will provide resources for investigators to work
collaboratively (governed by a Steering Committee, described below) to
develop, implement and assess a standardized protocol (or protocols)
for HTB (and related brain tissue) acquisition and processing that
renders the HTB specimens appropriate for modern molecular biologic
study, as well as an initial assessment of the HTBs acquired.
It is expected that applicants funded though this RFA will cooperate
with the Registry. The data arising from the HTBs collected, processed,
and assessed will be transmitted to the Registry for inclusion in its
HTB database. Digitized images of salient features of each HTB will be
created and made available to researchers in the greater scientific
community.
Applicants in response to this RFA must describe in detail a process
for:
1. defining and completing an initial HTB assessment protocol (or
protocols);
2. participating in Consortium collaborative protocols;
3. developing, implementing and testing acquisition and processing
protocols that allow for the application of advanced molecular biologic
assays;
4. developing and implementing HTB protocols that inform Consortium
collaborative protocols;
5. obtaining a clinical history, especially as relevant to
auditory/vestibular function;
6. obtaining regularly conducted clinical assessments, especially
auditory and vestibular function;
7. acquiring, processing, cataloging and storing HTB specimens;
8. cooperating with the Registry;
9. transmitting the findings from the initial assessment protocol to
the Registry;
10. cooperating with the Consortium Consulting Committee (defined
below)(do not name potential Consortium Consulting Committee members);
and,
11. digitizing and distributing salient images from processed HTBs.
In addition:
12. Applications for this RFA must provide detailed documentation
describing the ability of the Principal Investigator to assemble a
multidisciplinary team capable of carrying out the proposed processes.
Similarly, applicants must demonstrate the willingness, the ability and
a plan for conducting collaborative research endeavors with applicants
funded through this RFA.
13. Applicants interested in serving as Chair of the Steering Committee
(see below for definition) should provide detailed documentation of the
ability to provide executive leadership and scientific coordination and
should include a plan for implementing the scientific, operational, and
organizational policies of the Consortium, for managing the logistics
of the SC meetings and Consortium workshops/symposia, and for
information dissemination among the Consortium members, the Consortium
Consulting Committee (defined below), the Registry, and the NIDCD.
C. Consortium Administrative Structure
Organization: The Consortium comprises the PI and personnel of each HTB
laboratory funded under this RFA.
The HTB laboratory personnel should comprise not only those individuals
traditionally involved in temporal bone processing but also individuals
(e.g., pathologists, molecular biologists) whose expertise will be
important to the “modernization” of HTB research.
Steering Committee (SC): The SC is responsible for scientific
management and oversight, including monitoring the activities of the
Consortium. For the administrative structure, and responsibilities of
the SC, see “Collaborative Responsibilities.”
Consortium Consulting Committee (CCC): Established by the NIDCD after
the funding of all Consortium PIs, the CCC advises the SC on relevant
scientific issues, including study design, prioritization of technique
development, and the development of collaborative study protocols. For
further details, see “Collaborative Responsibilities.”
Headquarters: The institution of the SC Chair serves as the
Headquarters of the Consortium. The SC Chair can be any Principal
Investigator (PI) involved in the Consortium. The Chair serves as the
PI of the Headquarters and implements the scientific, operational, and
organizational policies of the Consortium. The Headquarters provides
the executive leadership and scientific coordination for the
Consortium. It serves as a center for information dissemination among
the Consortium PIs, the CCC, the Registry and the NIDCD. The
Headquarters manages the logistics of the SC meetings and Consortium
workshops/symposia.
Funds: Funds will reside with the individually funded awardees of the
Consortium.
The PIs of the awards will have funds available to support the
development, implementation, and assessment of the common HTB
acquisition and processing protocol, and to cover applicable
administrative costs and travel to Consortium SC meetings and
workshops.
MECHANISM OF SUPPORT
This RFA will use the NIH Cooperative Agreement (U24) award mechanism.
The NIH U24 is a cooperative agreement award mechanism. In the
cooperative agreement mechanism, the PI retains the primary
responsibility and dominant role for planning, directing, and executing
the proposed project, with NIH staff being substantially involved as a
partner with the PI as described under the section "Cooperative
Agreement Terms and Conditions of Award".
As an applicant you will be primarily responsible for planning,
directing, and executing Consortium collaborative studies. This RFA
will have one submission date: November 15, 2004. The anticipated award
date is July 2005. Investigators may not submit more than one
application for this RFA. NIDCD program intentions beyond the current
RFA are indefinite.
This RFA uses just-in-time concepts. U24 is not a modular mechanism.
This program does not require cost sharing as defined in the current
NIH Grants Policy Statement at:
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.
FUNDS AVAILABLE
NIDCD intends to commit approximately $1 million in FY 2005 to fund two
to three new grants in response to this RFA. An applicant may request a
project period of up to five years. Because the nature and scope of
the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary.
Although the financial plans of the NIDCD provide support for this
program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of
meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
The PIs funded under this RFA will establish a Steering Committee
(detailed below) to provide oversight for the development of a common
protocol (or protocols) for HTB acquisition and processing that allows
for advanced molecular biologic assessment. Each PI will be a voting
member of the SC and will attend two SC meetings each year. The PIs
will organize and attend at least two workshops/symposia during the
project period to inform the scientific community of the progress made
toward development and application of HTB acquisition and processing
techniques developed through awardee collaboration. Attendance at these
meetings is required as part of this cooperative agreement.
Cooperative Agreement Terms and Conditions of Award
These special Terms of Award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR Parts 74 and 92, and other HHS,
PHS, and NIH Grant Administration policy statements. [Part 92 applies
when state and local governments are eligible to apply as a "domestic
organization."]
Under the cooperative agreement, the NIDCD purpose is to support and/or
stimulate the recipient's activity by involvement in and otherwise
working jointly with the award recipient in a partner role, but it is
not to assume direction, prime responsibility, or a dominant role in
the activity. Consistent with this concept, the dominant role and prime
responsibility for the activity resides with the awardee(s) for the
project as a whole, although specific tasks and activities in carrying
out the studies will be shared among the awardees and the NIDCD Program
Coordinator.
A. Rights and Responsibilities of Human Temporal Bone Research
Resource Enhancement Consortium PIs
Collaborative Studies:
Each PI will collaborate with other Consortium awardees to develop a
common protocol for HTB (and related brain tissue) acquisition and
processing that enables modern molecular biologic evaluation.
Each PI will be responsible for accepting and implementing the goals,
priorities, common protocols, procedures, and policies agreed upon by
the Steering Committee (SC – see C.1. below for details) for the
collaborative studies.
Each PI will be responsible for collaborating on common research
designs or protocols, including methods and requirements for joint
participation and collaboration as recommended by the SC, and handling
of data, including appropriate sharing of methods and data among
collaborating organizations.
Each PI will be responsible for acquiring, processing and performing
the initial evaluation of HTB specimens for studies approved by the SC.
Each PI will develop procedures for study monitoring to assure
compliance with protocol designs and protection of patients from
research risk.
Each PI will assume responsibility for managing their laboratory’s
participation in collaborative projects approved by the SC.
Each PI will monitor and maintain appropriate records for protocols,
informed consents, assurances, and annual certifications of
Institutional Review Board (IRB) review and approval (OMB No. 0990-
0263, "Protection of Human Subjects, Assurance Identification/IRB
Certification/Declaration of Exemption, (Common Rule)
"http://www.hhs.gov/ohrp/humansubjects/assurance/OF310.rtf”).
Each PI will assume responsibility and accountability to the applicant
organization officials and to the NIDCD for the performance and proper
conduct of the research supported by the U24 in accordance with the
terms and conditions of the award.
Each PI will retain custody of and have primary rights to the data
developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies.
B. NIDCD Extramural Staff Responsibilities
The NIDCD Program Coordinator will have substantial scientific
programmatic involvement during conduct of this activity, through
technical assistance, data sharing and analysis, composition of
reports, and advice and coordination above and beyond normal program
stewardship for grants as described below.
The Program Coordinator will convene the initial meeting of the SC,
have voting membership on the SC, and, as determined by that committee,
its subcommittees.
Although the PI will have lead responsibilities in all collaborative
tasks and activities, it is anticipated that the NIDCD Program
Coordinator will have lead responsibilities in managing and sharing the
broad programmatic issues among awardees.
An NIDCD Program Official will also be responsible for normal
programmatic stewardship and monitoring of the awards. The NIDCD
Program Official may serve as the NIDCD Program Coordinator.
The NIDCD reserves the right to adjust funding, withhold support,
suspend, terminate or curtail a study or an individual award in the
event of: a failure to comply with the Terms and Conditions of Award; a
substantial shortfall in HTB specimen acquisition, processing, or
evaluation; lack of data reporting or quality control; other major
breach of scientific conduct; or human subject ethical issues, whenever
applicable.
C. Collaborative Responsibilities
1. Steering Committee (SC):
The SC will have major scientific management oversight and
responsibility for developing collaborative research projects,
facilitating the conduct and monitoring of studies, and reporting study
results.
The SC will be composed of the PI from each awardee institution and the
NIDCD Program Coordinator. Each member will have one vote. The Chair
(non-NIH person) will be selected by the SC. The institution of the SC
Chair serves as the Headquarters of the Consortium. The SC Chair can be
any Principal Investigator (PI) involved in the Consortium. The SC
Chair serves as the PI of the Headquarters and implements the
scientific, operational, and organizational policies of the Consortium.
The Headquarters provides the executive leadership and scientific
coordination for the Consortium. It serves as a center for information
dissemination among the Consortium PIs, the CCC, the Registry and the
NIDCD. The Headquarters manages the logistics of the SC meetings and
Consortium workshops/symposia.
1. After all the Consortium awardees have been funded, the SC will
convene. Thereafter, the SC will meet twice yearly. Responsibilities
of the SC include but are not limited to:
o developing and refining a common protocol (or protocols) for HTB
acquisition, processing and initial evaluation;
o developing collaborative policies and procedures, including
publication policies;
o developing policies and procedures for maintaining liaison and
sharing data with the Registry;
o developing policies and procedures for reviewing changes in projects
not showing promise; and,
o developing standards or “decision criteria” for pursuing techniques
for further study.
2. The SC will review HTB accrual, protocol compliance, results of
audits, and regulatory requirements at the participating laboratories
and formally report the results of its reviews to the NIDCD.
3. The SC will promote and foster the inclusion of women and ethnic
minorities in clinical studies and assure the completeness of informed
consent.
4. The SC will track collaborative research progress and assure that
the results are published in peer-reviewed journals in a timely manner
and in accordance with established publication policies.
5. The SC will discuss, develop and implement collaborative projects to
be pursued jointly.
6. Collaborative studies/protocols will be approved by the SC. Data
will be submitted to the Headquarters. The SC will define the rules
regarding access to data and publications consistent with NIDCD
policies.
8. The SC will plan at least two workshops/symposia during the project
period to inform the scientific community of the progress made toward
development and application of HTB acquisition and processing
techniques developed through awardee collaboration. The Consortium
Consulting Committee and the NIDCD Program Coordinator will provide the
SC with advice on participants for the workshops and symposia. The
Headquarters will manage the logistics for these meetings.
2. Consortium Consulting Committee (CCC):
1. Established by the NIDCD, the CCC advises the SC on relevant
scientific issues, including study design, prioritization of technique
development, and the development of collaborative study protocols.
2. The membership of the CCC and duration of service will be
established by the NIDCD in consultation with the SC. The membership
includes researchers/institutions not participating in the Consortium.
The CCC will include molecular biologists, pathologists, and temporal
bone researchers.
3. The Chair of the CCC is elected by its members. The Chair of the SC
also serves as an ad hoc member of this advisory committee. The NIDCD
is represented by relevant program staff, which will be responsible for
meeting logistics.
4. The CCC advises the NIDCD on the progress and success of the
Consortium against the criteria developed by the SC.
5. The CCC helps the NIDCD in site visits to the participating
institutions, as necessary.
6. The CCC collaborates with the SC to suggest participants for and to
assist in the implementation of workshops and symposia and to provide
liaison between the human temporal bone research community and the
Consortium.
7. The CCC will meet at least once yearly in the Bethesda, MD area.
D. Arbitration
A panel will be formed to review any scientific or programmatic
disagreement (within the scope of the U24 award) between the award
recipients and the NIDCD. The panel will be composed of three members:
one selected by the SC (with the NIDCD Program Coordinator not voting);
a second member selected by the NIDCD; and, the third member selected
by the two prior selected members. Any disagreement that may arise on
scientific/programmatic matters (within the scope of the award) between
award recipients and the NIDCD may be brought to arbitration.
This special arbitration procedure in no way affects the awardee's
right to appeal an adverse action that is otherwise appealable in
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and
HHS regulation at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
A. Julianna Gulya, MD
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400D-7
MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 435-4085
FAX: (301) 402-6251
Email: julie_gulya@nih.gov
o Direct your questions about peer review issues to:
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400C
MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: s8k@cu.nih.gov
o Direct your questions about financial or grants management matters
to:
Chief, Grants Management Branch
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400B
MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: stones@nidcd.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows NIDCD staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
A. Julianna Gulya, MD
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400D-7
MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 435-4085
FAX: (301) 402-6251
Email: julie_gulya@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS (please also refer to “SPECIAL REQUIREMENTS”
listed above)
Special Instructions for Preparation of the Application
1. COMPLIANCE WITH TERMS OF THE CONSORTIUM COOPERATIVE AGREEMENT
In a separate, labeled section, specific issues related to the
cooperative agreement must be addressed.
Applicants must include their specific plans for responding to the
“Cooperative Agreement Terms and Conditions of Award” section.
Applicants should state their willingness to collaborate and share data
freely with the other Consortium members, to participate in planning
and attending workshops and symposia, to serve on the SC and be bound
by its decisions, and to share data and research resources with each
other and the NIDCD. Successful applicants will be expected to submit
information on specimen collections to the Registry (through the
Headquarters).
At the end of this section, applicants must append a letter from the
applicant institution describing how that institution intends to meet
the NIH policies for sharing of data or why data sharing is not
possible. In this regard, attention is drawn to the NIH Final Statement
on Sharing Research Data
(http://grants.nih.gov/grants/policy/data_sharing/index.htm and
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html),
which was published in the NIH Guide on February 26, 2003. This is an
extension of NIH policy on sharing research resources, and reaffirms
NIH support for the concept of data sharing. The new policy became
effective with the October 1, 2003 receipt date for applications or
proposals to NIH.
Applicants to this RFA must also include a research tools and resources
sharing plan in the letter to be appended to this section.
Investigators conducting biomedical research frequently develop unique
research resources. The policy of the NIH is to make available to the
public the results and accomplishments of the activities that it funds.
NIH recognizes that certain research activities may result in
inventions and that grantees are entitled to protect such inventions
through patenting and licensing activities in accordance with the Bayh-
Dole Act, 35 USC § 200 et seq. and the implementing regulations, 37 CFR
Part 401 (“Bayh-Dole Act”). However, the Consortium’s mission of
collaboration among Consortium members and between Consortium members
and the larger community of researchers necessarily anticipates the
sharing of intellectual property arising out of research resources
developed in Consortium-related activities. To address the interest in
assuring that research resources are accessible, NIH expects applicants
who respond to this RFA to submit plans (1) for sharing the unique
research resources generated through the grant; and (2) for addressing
how they will exercise intellectual property rights, should any be
generated through this grant, while making such research resources
available to the broader scientific community.
The sharing of research resources and intellectual property plans must
make unique research resources readily available for research purposes
to qualified individuals within the scientific community in accordance
with the NIH Grants Policy Statement
(http://grants.nih.gov/grants/policy/nihgps/) and the Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical Research Resources: Final
Notice, December 1999
(http://www.ott.nih.gov/policy/rt_guide_final.html and
http://ott.od.nih.gov/NewPages/64FR72090.pdf)(“NIH Research Tools
Guidelines”).
These documents define terms, parties, and responsibilities. The
documents also prescribe the order of disposition of rights, and a
chronology of reporting requirements and delineate the basis for and
extent of government actions to retain rights. Patent rights clauses
may be found at 37 CFR Part 401.14 and are accessible from the
Interagency Edison web page, (http://www.iedison.gov); see also, 35 USC
§ 210(c); Executive Order 12591, 52 FR 13414 (Apr. 10, 1987); and
Memorandum on Government Patent Policy (Feb. 18, 1983).
2. APPLICANTS FOR STUDY CHAIR
Applicants interested in serving as Chair of the Steering Committee
should provide detailed documentation of their ability to provide
executive leadership and scientific coordination. They should include a
plan for implementing the scientific, operational, and organizational
policies of the Consortium, for managing the logistics of SC meetings
and Consortium workshops/symposia, and for information dissemination
among the Consortium members, the CCC, the Registry, and the NIDCD.
3. BUDGET
1. Applicants must budget for travel and per diem expenses for SC
meetings. In the first year, applicants should plan for the Principal
Investigator and an additional senior investigator to attend a Planning
Meeting and two Steering Committee meetings. In the second and
subsequent years, applicants should plan for the Principal Investigator
and an additional senior investigator to attend two SC meetings per
year.
2. Applicants must budget for travel and per diem expenses for
participation in Consortium workshops and symposia. Applicants should
plan that at least two investigators will attend at least two
Consortium workshops/symposia.
3. Applicants interested in serving as SC Chair must budget for
expenses solely related to the Headquarters function (see above) and
the yearly meetings of the CCC; only the applicant elected Chair will
be awarded such budgeted funds. The use of these set aside funds will
be restricted and be released from the U24 by NIDCD. Indicate this
amount in the “Other Expenses” category under the heading “Headquarters
Funds”.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400C
MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6250
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIDCD. Incomplete applications will not be
reviewed. If the application is not responsive to the RFA it will be
returned without review.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDCD, in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, may be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Deafness and Other
Communication Disorders Advisory Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting them
as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
SIGNIFICANCE: Does the proposed work enhance research resources for
HTBs?
APPROACH: Are the plans for developing, assessing and implementing a
standardized protocol (or protocols) for HTB acquisition and processing
adequately developed and appropriate to the aims of the Consortium?
Does the applicant acknowledge potential problem areas and consider
alternative tactics? Is the timeline for the proposed work reasonable?
Are organizational and administrative plans likely to lead to a well
functioning, cohesive research group?
Are there adequate plans for effective interaction and collaboration
with the Consortium components, the Steering Committee, the Consortium
Consulting Committee, the Registry, and the NIDCD?
For applicants interested in serving as Steering Committee Chair: are
there adequate plans for accomplishing the tasks of the SC Chair? Are
the plans for information dissemination among the components of the
Consortium, the Registry, the Consortium Consulting Committee and the
NIDCD adequate? Are the plans for managing meeting logistics adequate?
INNOVATION: Will the project provide improved utility, methodologies,
or knowledge to facilitate researcher use of HTBs?
INVESTIGATOR: Are the investigator and key personnel sufficiently
knowledgeable, experienced and appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers? Does the
investigator propose the establishment of an appropriate
multidisciplinary team?
For applicants interested in serving as Steering Committee Chair: Does
the investigator demonstrate the requisite scientific, operational and
organizational skills?
ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Does the proposed work
take advantage of unique features of the scientific environment or
employ useful collaborative arrangements? Is there evidence of
institutional support?
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
ADDITIONAL REVIEW CONSIDERATIONS
PLAN FOR SHARING RESEARCH RESOURCES
The reviewers will provide an administrative comment evaluating the
adequacy and feasibility of the resource sharing plan. Recommendations
regarding such plans are at
http://www.ott.nih.gov/policy/rt_guide_final.html. This comment will
not affect the priority score of the proposal. NIH staff will consider
the adequacy of the plan in determining whether to recommend an
application for award. The sharing plan as approved, after negotiation
with the applicant as necessary, will become a condition of the grant
award.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 15, 2004
Application Receipt Date: November 15, 2004
Peer Review Date: Feb/Mar 2005
Council Review: May 2005
Earliest Anticipated Start Date: July 2005
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
SHARING RESEARCH DATA: Investigators submitting an NIH application
seeking $500,000 or more in direct costs in any single year are
expected to include a plan for data sharing or state why this is not
possible. http://grants.nih.gov/grants/policy/data_sharing
Investigators should seek guidance from their institutions, on issues
related to institutional policies, local IRB rules, as well as local,
state and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority
score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the “Standards for Privacy of Individually Identifiable
Health Information”, the “Privacy Rule,” on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on “Am
I a covered entity?” Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.